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To evaluate the viral and immunological factors directly related to milk transmission of virus, we have evaluated the disease course of Simian Immunodeficiency Virus SIV in lactating rhe

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Open Access

Research

Viral and immunological factors associated with breast milk

transmission of SIV in rhesus macaques

Angela M Amedee*1, Jenna Rychert1, Nedra Lacour1, Lynn Fresh2 and

Address: 1 Department of Microbiology, Immunology, Parasitology, Louisiana State University Health Sciences Center, New Orleans, LA USA and

2 Department of Veterinary Medicine, Tulane National Primate Research Center, Covington, LA, USA

Email: Angela M Amedee* - aamede@lsuhsc.edu; Jenna Rychert - jryche@lsuhsc.edu; Nedra Lacour - nlacou@lsuhsc.edu;

Lynn Fresh - lynn@tpc.tulane.edu; Marion Ratterree - ratt@tpc.tulane.edu

* Corresponding author

Abstract

Background: The viral and host factors involved in transmission of HIV through breastfeeding are

largely unknown, and intervention strategies are urgently needed to protect at-risk populations To

evaluate the viral and immunological factors directly related to milk transmission of virus, we have

evaluated the disease course of Simian Immunodeficiency Virus (SIV) in lactating rhesus macaques

(Macaca mulatta) as a model of natural breast milk transmission of HIV.

Results: Fourteen lactating macaques were infected intravenously with SIV/DeltaB670, a

pathogenic isolate of SIV and were pair-housed with their suckling infants throughout the disease

course Transmission was observed in 10 mother-infant pairs over a one-year period Two mothers

transmitted virus during the period of initial viremia 14–21 days post inoculation (p.i.) and were

classified as early transmitters Peak viral loads in milk and plasma of early transmitters were similar

to other animals, however the early transmitters subsequently displayed a rapid progressor

phenotype and failed to control virus expression as well as other animals at 56 days p.i Eight

mothers were classified as late transmitters, with infant infection detected at time points in the

chronic stage of the maternal SIV disease course (81 to 360 days) Plasma viral loads, CD4+ T cell

counts and SIV-specific antibody titers were similar in late transmitters and non-transmitters Late

breast milk transmission, however, was correlated with higher average milk viral loads and more

persistent viral expression in milk 12 to 46 weeks p.i as compared to non-transmitters Four

mothers failed to transmit virus, despite disease progression and continuous lactation

Conclusion: These studies validate the SIV-infected rhesus macaque as a model for breast milk

transmission of HIV As observed in studies of HIV-infected women, transmission occurred at time

points throughout the period of lactation Transmission during the chronic stage of SIV-infection

correlated with a threshold level of virus expression as well as more persistent shedding in milk

This model will be a valuable resource for deciphering viral and host factors responsible for

transmission of HIV through breastfeeding

Published: 14 July 2004

Retrovirology 2004, 1:17 doi:10.1186/1742-4690-1-17

Received: 05 May 2004 Accepted: 14 July 2004 This article is available from: http://www.retrovirology.com/content/1/1/17

© 2004 Amedee et al; licensee BioMed Central Ltd This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL

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Mother-to-infant transmission is the primary cause of

HIV-1 infection in children worldwide, with an estimated

700,000 children infected in 2003 [1] Transmission

through breastfeeding accounts for at least one-third of

these infections, however it is difficult to differentiate

perinatal transmission from early milk transmission [2-4]

Meta-analysis of several cohorts has estimated that 14% of

mothers chronically-infected with HIV transmit virus to

their infant through breastfeeding, whereas 29% of

women who acquire primary HIV infections during

lacta-tion transmit virus to their infants [5] Since breastfeeding

is unavoidable in many countries in which the HIV-1

epi-demic is most severe, it is necessary to understand risk

fac-tors associated with breast milk transmission and the

underlying viral and immunological mechanisms

respon-sible for transmission

Epidemiological studies of HIV-1 infected women and

their infants have identified several risk factors for milk

transmission of HIV, as recently reviewed by Read et al [6]

Reduced levels of innate immune factors including

lacto-ferrin, lysozyme and secretory leukocyte protease

inhibi-tor (SLPI), as well as insufficient secreinhibi-tory IgA responses

have been associated with higher rates of HIV

transmis-sion through milk [7-10] Conditions affecting the

mucosal epithelium, such as mastitis, and oral candidiasis

in the infant, have also been identified as risk factors for

milk transmission of HIV [4,11-13] In addition, several

studies have shown that longer durations of breastfeeding

increase the cumulative risk of milk transmission

[3,4,14-16]

One of the most consistently documented risk factors of

mother-to-infant transmission through milk is advanced

maternal disease as measured by higher plasma viral loads

and lower CD4+ T cell counts [12,17-19] Although this

risk factor has been identified in several cohorts,

transmis-sion occurs by mothers with a wide range of plasma viral

loads and CD4+ T cell counts, and an absolute level of

these markers has not been associated with transmission

[20-22] Longitudinal evaluations of HIV-infected women

in a Nairobi clinical trial study have shown that

transmis-sion of HIV through milk is associated with higher levels

of viral RNA in milk as well as with consistent shedding of

virus in milk [23] Although this study estimated that each

log increase in milk viral load doubled the risk of

trans-mission, they were unable to identify a milk viral

thresh-old level required for transmission The frequency of

sampling and constant fluctuations in milk virus levels

may explain these observations

The epidemiological findings observed in humans have

not been evaluated in an animal model that could allow

the identification of viral and host factors directly

respon-sible for transmission through breastfeeding The SIV infected rhesus macaque has successfully been used as a model of HIV transmission and pathogenesis Although disease progression is more rapid in macaques infected with SIV than in HIV infected humans, macaques exhibit

a similar disease course and succumb to opportunistic infections much the same as infected humans [24] We have previously reported breast milk transmission of SIV

in experimentally infected rhesus macaques (Macaca mulatta) [25], and in this report, we expand our

observa-tions and examine the correlation between milk transmis-sion of SIV and levels of virus in maternal plasma and milk samples, levels of peripheral CD4+ T cells, and titers

of SIV-specific antibodies in milk and plasma from 14 lac-tating macaques

Results

Outcome of SIV infection of lactating macaques

Fourteen lactating macaques were inoculated intrave-nously with a pathogenic SIV inoculum, SIV/DeltaB670 [26], to evaluate mother-to-infant transmission through breastfeeding Each animal had a suckling infant at the time of inoculation and all mothers were PCR positive for SIV at 7 days post inoculation (p.i.) Mother-infant pairs were monitored daily for clinical signs of disease progres-sion Infant blood samples were collected weekly for 8 weeks for SIV PCR amplification, followed by biweekly and then monthly testing

As summarized in Table 1, 10 of 14 infants became PCR positive for SIV over the course of the study Two infants were rapidly infected as determined by PCR amplification

of SIV sequences from infant PBMCs 14 and 21 days after inoculation of the mothers The mothers, P173 and T243, were labeled as early transmitters Two additional infants were identified as SIV-infected at 81 and 84 days post inoculation of the mothers, and six infants were SIV posi-tive at time points ranging from 235–360 days post inoc-ulation Because these eight mothers transmitted virus at later times points in their disease course, they were labeled as late transmitters Four infants were consistently SIV-negative by PCR amplification, despite progression of SIV disease and continued lactation in the non-transmit-ting mothers Two of these infants repeatedly tested SIV-negative in PBMC for at least 1 year after removal from the dam The other two of the four SIV-uninfected infants, monkeys CK56 and DP79, were euthanized at the same time point as their mother for reasons unrelated to SIV PCR and RT-PCR analysis of PBMC, plasma, spleen, lymph node and thymus obtained at the time of necropsy were all negative for SIV

The age of infants at the time point of maternal inocula-tion varied from 7 to 54 days (table 1) Although the ages varied at the time of maternal inoculation and the volume

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of milk ingested by each infant could not be controlled,

associations between infant age, maturity of milk and the

timing of transmission could not be identified The two

infants infected early were representative of the range of

infant ages, at 7 and 43 days of age at the time of maternal

inoculation The four infants that remained uninfected

despite disease progression displayed a similar age

distri-bution at the start of the study at 8, 14, 26 and 54 days of

age Infants classified as late transmission ranged from 7–

54 days of age at the start of the study All females

contin-ued to lactate throughout the study period

Disease course

Each of the 14 mothers developed clinical signs of SIV

dis-ease over the one-year study period, which included

cachexia, weight loss, diarrhea, lymphadenopathy, and/or

pneumonia The two early transmitters progressed to end

stage disease rapidly Monkey P173 was euthanized 143

days p.i with end stage disease caused by cytomegalovirus

(CMV) infection, and monkey T243 was euthanized 132

days p.i with interstitial pneumonia Clinical signs of

dis-ease were evident in each of the late transmitting females

near the time of transmission, but symptoms varied

widely

The time points of euthanization for late transmitters

ranged from 143 to 373 days p.i Each of the late

transmit-ters was sacrificed with clinical signs of disease at the end

of the study period, although end stage disease had not

necessarily been reached in all of these monkeys at the

time of euthanization Three of the four non-transmitters

progressed to end stage disease during the study period

and were sacrificed due to opportunistic infections

includ-ing disseminated CMV, cryptosporidium, or adenovirus The fourth non-transmitter (monkey AA26) died sud-denly while housed with her infant Necropsy revealed the cause of death in monkey AA26 to be colitis, but lym-phoid hyperplasia and loss of 6% body weight were also evident

Analysis of CD4+, T cells

To evaluate the level of immunosupression in the moth-ers, CD4+ T cell counts were determined by flow cytometic evaluation of blood samples on the day of inoc-ulation and at several time points over the course of dis-ease (Figure 1), as previously described [27] At the time

of inoculation (day 0), a wide range of CD4+ T-cell counts were found in the females, varying from 600 to over 3000 cells/µl Two weeks p.i., a decrease in the number of CD4+

T cells was observed in all animals Cell counts remained

at these low levels in the two early transmitters (yellow symbols), but rebounded to varying levels in the other 12 animals No significant differences in cell counts were observed between non-transmitting and late transmitting mothers at any point in the disease course, with only a few animals dropping to CD4+ T cell counts below 400 cells/

µl at any time point The ratio of CD4+/CD8+ T cells was also compared in each of the monkeys; however, signifi-cant differences were not observed, between the transmis-sion groups (data not shown)

Viral load

Viral RNA levels in plasma and milk were determined by real-time quantitative RT-PCR at several time points throughout the one year study period to evaluate the rela-tionship between viral load and transmission As shown

Table 1: Outcome of SIV Infection of 14 Dams 7–54 days after delivery

Mother Infant Infant age @ start SIV Infection in

Infant

Timepoint of SIV Detection in Infant (days p.i.)

Last Negative Timepoint in Infant (days p.i.)

T182 CK36 18 + 84 72

H327 DT97 7 + 235 217

T802 DR88 9 + 252 238

N007 BN86 54 + 258 223

P168 CI47 42 + 290 258

P403 CK35 18 + 318 290

G627 DP66 8 + 360 346

P650 CK56 14 - - 196 ** P243 CI24 54 - - 140** AA26 CJ99 26 - - 258** T722 DP79 8 - - 286**

** Time point infant was removed from dam due to disease progression in dam

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in Figure 2A, plasma viral RNA loads in each of the

moth-ers peaked two weeks post-inoculation with levels ranging

from 1 × 106 to 1 × 108 copies/ml Average plasma viral

loads at 14 days p.i were similar for the transmitting and

non-transmitting mothers (Figure 3) At 8 weeks p.i.,

plasma viral loads reached set point levels The four

non-transmitting mothers had average viral loads at set point,

ranging from 4 × 105 to 6 × 106 copies/ml, and similar

lev-els persisted until end stage disease The eight late

trans-mitters generally had lower plasma viral loads at 8 weeks

p.i than non-transmitters (p = 0.048) ranging from 1 ×

104 to 2 × 106 copies/ml Plasma viral loads in the late

transmitters increased as disease progressed, reaching

lev-els similar to non-transmitters

Milk viral loads, like plasma, were the highest at 2 weeks

p.i in all of the mothers, ranging from 2 × 103 to 4 ×

105copies/ml (Figure 2B) Viral loads in early transmitters were not significantly higher than other animals at 14 days p.i (Figure 3) Each mother displayed individual pat-terns of virus shedding in milk throughout the disease course, with many having low (≤50 copies/ml) or unde-tectable milk viral loads at some time points, while at other time points levels were as high as 1 × 104 copies/ml

To evaluate the levels and persistence of virus expression

in milk at later time points during the disease course, we compared average milk viral loads as well as the highest milk viral load detected at any time point 12–46 weeks p.i in each mother As shown in Table 2, average and peak milk viral RNA levels in all non-transmitters were below

500 copies/ml during this time, with average viral loads ranging from <50 to 357 viral copies/ml In contrast, late transmitters had at least one milk sample with more than

500 copies virus/ml and six of the eight late transmitters

CD4+ T Cell Counts in Lactating Macaques

Figure 1

CD4+ T Cell Counts in Lactating Macaques CD3+, CD4+ cell counts in peripheral blood of lactating macaques at

vari-ous time points post-inoculation with SIV The day of inoculation is represented by the 0 time point Cell counts for individual monkeys are shown and the means of each transmission group are represented in the line graph Early transmitters are shown

in yellow, late transmitters in red and non-transmitters in blue

CD4+ T Cells

0

500

1000

1500

2000

2500

3000

3500

Weeks Post Inoculation of Dam

Mean Early Transmitters Mean Late Transmitters Mean Non-Transmitters

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Viral Load in Lactating Macaques

Figure 2

Viral Load in Lactating Macaques Viral RNA copies were measured by real-time RT-PCR from (A) peripheral blood

plasma and (B) the cell-free fraction of milk samples obtained at indicated time points in each of fourteen lactating macaques Milk samples that could be amplified by PCR, but had values calculated as ≤50 copies RNA/ml (amplifiable but not quantifiable) were indicated as having 50 copies Samples from which viral RNA could not be amplified were indicated as having 1 copy Early transmitters are shown in yellow, late transmitters in red and non-transmitters in blue

PLASMA VIRAL LOAD

100 1000 10000 100000 1000000 10000000 100000000

2 5 8 12-14 18-20 24-28 31-32 37 45-46

Weeks Post-Inoculation

A

MILK VIRAL LOAD

1 10 100 1000 10000 100000 1000000

2 5 8 12-14 18-20 24-28 31-32 37-40 45-46

Weeks Post-Inoculation

T243 P173 T802 H327 T364 G627 N007 P168 P403 T182 T722 AA26 P650 P243

B

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had milk samples with more than 1000 copies/ml over

this time period Peak milk virus levels observed 12–46

weeks p.i were significantly higher in late transmitting

animals than non-transmitters (p = 0.004) Over the same

period of time, late transmitters had higher average milk

viral loads than non-transmitters (p = 0.028),

demonstrat-ing more consistent shedddemonstrat-ing of virus in milk by late

transmitters throughout the disease course

SIV Specific Antibody

To evaluate humoral immune responses in SIV-infected

females and determine their association with

transmis-sion, levels of SIV envelope specific IgG in plasma and

milk were determined by ELISA As shown in Table 3,

peak SIV-specific plasma IgG titers ranging from 1:20,000

to 1:320,000 were found in late transmitter and

non-transmitter females, whereas lower titers of ≤1: 5,000 were detected in the two early transmitters Milk titers of env-specific IgG were 1–3 logs lower than plasma IgG titers in all monkeys, with the two early transmitters again display-ing the lowest milk IgG titers (Table 3) SIV-specific IgA responses in milk were 5-fold lower than IgG titers in milk

of all monkeys, with levels ranging from undetectable to 1:10 in early transmitters monkeys T243 and P173, respectively, and varying from 1:10 to 1:500 in all other animals Low titers, or the absence of virus-specific IgA in milk of HIV-infected women have also been reported [7,28-32] SIV envelope specific plasma IgG, milk IgG, and milk IgA titers remained relatively stable throughout the disease course, including time points near transmis-sion of virus to the infant (data not shown) All late transmitters females had IgG titers in milk and plasma

Mean Plasma and Milk Viral Loads in Early, Late and Non-Transmitting Macaques

Figure 3

Mean Plasma and Milk Viral Loads in Early, Late and Non-Transmitting Macaques Viral RNA copies measured by

real-time RT-PCR in cell-free fraction of milk samples obtained from lactating macaques Samples that could be amplified by PCR, but had values calculated as having ≤50 copies RNA/ml (amplifiable but not quantifiable) were indicated as having 50 cop-ies Samples from which viral RNA could not be amplified were indicated as having 1 copy Early transmitters are shown in yel-low, late transmitters in red and non-transmitters in blue

MEAN VIRAL LOAD in PLASMA and MILK

10 100 1000 10000

100000

1000000

10000000

100000000

Weeks Post-Inoculation

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similar to non-transmitters, indicating that high titers of

SIV-envelope specific antibodies did not protect infants

from infection The two early transmitters failed to

pro-duce levels of SIV envelope antibody comparable to other

animals by 98 days p.i a characteristic commonly

identi-fied with rapid progression of SIV disease [24]

Discussion

This study is the first to describe the viral and

immunolog-ical correlates of breast milk transmission in lactating

SIV-infected macaques Following intravenous inoculation of

females, transmission through breastfeeding was observed in 10 of 14 macaque mother-infant pairs By inoculating mothers after delivery with a highly patho-genic strain of SIV, (SIV/DeltaB670) the viral and immu-nological parameters related solely to breast milk transmission could be evaluated in the absence of

poten-tial in utero and peri-partal transmission With this model,

an accelerated disease course was observed coincident with the period of lactation, and is likely responsible for the high rate of transmission that occurred Despite acute infection of lactating mothers and the accelerated disease

Table 2: Average and Peak Milk Viral Loads 8–46 weeks p.i.

Dam Peak Milk Viral Load 12–46 wks p.i Average Milk Viral Load 12–46 wks p.i.

Transmitters

Non-Transmitters

Comparison Late and Non-Transmitters p = 0.004 p = 0.028

Table 3: SIV-envelope specific IgG titers in Plasma and Milk

Day 98 SIV IgG Titer*

Rapid Transmitters

P173 5,000 50 T243 <5,000 <50

Late Transmitters

T364 80,000 1,600 N007 320,000 1,600 T182 320,000 6,400 H327 80,000 400 T802 320,000 1,600 P168 320,000 6,400 P403 320,000 1,600 G627 80,000 1600

Non-Transmitters

P650 320,000 100 P243 20,000 100 AA26 320,000 1,600 T722 80,000 1,600

* titers = reciprocal of the sample dilution that gave a positive OD reading at 450 nm Plasma and milk samples were diluted 4-fold.

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course in this model, transmission to infants was not

uni-form Transmission occurred at various time points

throughout the period of lactation, while four infants

remained uninfected These results are similar to

observa-tions made in HIV-infected women, where infant

infec-tion through breastfeeding occurs throughout the course

of lactation [19,33] This model therefore provides a

resource for deciphering the mechanisms involved in

breast milk transmission of HIV

Eight mothers transmitted virus to their infants during the

chronic phase of the disease course, at time points ranging

from 81 to 360 days p.i These late transmitting mothers

had similar plasma viral loads and similar courses of

dis-ease progression as compared to non-transmitting

moth-ers Transmitting mothers, however, had one or more

milk samples with greater than 500 copies of viral RNA/

ml, and expressed higher average milk viral loads than

non-transmitters over the chronic stage of disease These

results are consistent with observations in HIV-infected

women that higher milk viral loads and consistent

shed-ding of virus in milk correlate with infant infection [23]

Due to frequent longitudinal sampling and the controlled

environment provided by the macaque model, this

corre-late of transmission was more precisely defined in the SIV

model than in cohorts of HIV infected women

Despite disease progression in the mothers, four infants

remained uninfected in this study Each of the

non-trans-mitters continued to lactate and remained housed with

their infant until at end-stage disease Although plasma

viral loads and CD4+ T cell counts were similar to those in

late transmitting mothers, milk viral loads were less than

500 copies/ml at each time point evaluated These results

suggest that the dynamics of virus expression in milk are

critical to infant infection Macaques that display a profile

of high plasma viral load, with low levels of virus

expres-sion in milk will be valuable tools for deciphering the

viral properties and mechanisms responsible for

expres-sion in milk

While viral levels in milk could be identified as a correlate

of transmission during the chronic stage of disease, milk

viral loads never returned to levels as high as those

observed during peak viremia at 14 days p.i This implies

that multiple factors, in addition to absolute levels of

virus are responsible for infant infection through

breast-feeding During the period of acute viremia only two of 14

infants became SIV-infected through breastfeeding,

despite exposure to high levels of virus in milk and the

absence of SIV-specific immune responses Viral loads in

milk and plasma at 14 and 21 days p.i were similar in all

mothers, as were CD4+ T cell counts The two early

trans-mitting females, however, progressed to end stage disease

rapidly and were found to have lower titers of

envelope-specific antibody by day 98 p.i., as compared to the remaining 12 animals Early transmitters also had the highest plasma virus levels at 56–98 days p.i., failed to recover numbers of CD4+ T cells after the initial loss observed at 14 days p.i., and were euthanized due to end-stage disease before 5 months This profile of rapid disease progression in SIV-infected macaques has been reported and characterized by others [34-36]

From these observations it can be hypothesized that the same host responses that are unsuccessful in controlling the initial viremia in the lactating mother are also respon-sible for transmission of virus to the infant Similarly, the ability of most infants to resist infection in this experimental model, despite oral exposure to high levels

of virus in milk, provides an opportunity to decipher the innate responses that provide protection to the infant Breast milk contains numerous factors with antimicrobial and immunomodulatory properties that may affect trans-mission to the infant and several factors in infant saliva are likely to provide protection against oral virus exposure

(reviewed by Kourtis et al.) [37] Higher levels of secretory

leukocyte protease inhibitor (SLPI) in the saliva of infants breast fed by HIV-infected mothers has been correlated with a decreased risk of infection by 1 month of age [38] Innate protective responses in infant saliva, as well as breast milk were not evaluated in this study due to sample limitations, but should be addressed in future studies with this model

Titers of envelope specific IgA in milk of SIV-infected macaques were at least five-fold lower than levels of spe-cific IgG in milk These observations are consistent with those reported in HIV-infected women, where low levels

of HIV-specific IgA are commonly found, despite normal levels of total IgA [30-32,39] Although the lack of IgA responses against SIV may contribute to transmission, they cannot be directly responsible, as four infants remained SIV-uninfected despite the lack of maternal envelope-specific IgA and similar levels of SIV-specific IgG Similarly the levels of SIV specific IgG cannot play a direct role in protection, since late transmitters and non transmitters developed similar titers of envelope specific IgG Future studies in this model can be designed to address the role of immune evasion in breast milk trans-mission of virus

Virus expressed in the cell-associated fraction of milk may also play a key role in transmission, however sample lim-itations did not allow these analyses in this study Quan-titation of the cell-associated viral load in milk and characterization of the viral genotypes/phenotypes expressed in cell-associated and cell-free fractions of milk

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may help to define the viral factors responsible for infant

infection

Conclusions

This study has examined the viral and immunological

fac-tors associated with transmission of virus through

breast-feeding in a group of 14 lactating macaques infected with

SIV Mothers that transmitted virus to their infants

through breastfeeding during the chronic phase of the

dis-ease course exhibited disdis-ease correlates similar to those

reported in HIV-infected, transmitting women, and thus

supports the use of the SIV-infected lactating rhesus

macaque as a model In this well-controlled experimental

model, the main correlate of breast milk transmission

could be more precisely defined as the persistence of viral

expression in milk and the expression of higher viral levels

in milk as compared to non-transmitters The accelerated

SIV disease course in macaques resulted in a high rate of

transmission, however four infants remained uninfected

despite advanced disease in lactating mothers, modeling

the range of outcomes observed in humans Additionally,

our observation of rapid transmission by macaques with

a rapid progressor phenotype provides additional insights

into the factors responsible for control of primary viremia,

and the expression of virus in milk This model is a

valua-ble tool for the characterization of viral and host

mecha-nisms responsible for transmission of SIV/HIV through

breastfeeding and will help elucidate the responses that

provide protection from breast milk transmission

Methods

Animals

Eight female rhesus macaques (Macaca mulatta) were

selected for the study 15–54 days after vaginal delivery of

normal infants Six additional females were time mated

using exogenous progesterone administration and

with-drawal as described previously, [40] Time-mated females

were enrolled in this study 7–9 days after vaginal delivery

of normal infants The fourteen lactating dams were

inoc-ulated intravenously with 4 TCID50 doses of SIV/

DeltaB670, a primary SIV stock amplified on rhesus

pri-mary peripheral blood mononuclear cells (PBMC) [26]

Inoculations were performed via cannulation of the

saphaneous vein Lactating females were housed with

their infants and observed several times each day for signs

of illness and/or maternal neglect Animals that became

moribund were humanely sacrificed

All animal protocols were approved by the Tulane and

LSU Institutional Animal Care and Use Committees and

were in accordance with the Guide for the Care and Use of

Laboratory Animals [41] Animals were housed at the

Tulane National Primate Research Center, a facility

accredited by the Association for Assessment and

Accreditation of Laboratory Animal Care (AAALAC)

Inter-national Animals were housed in standard stainless steel cages in a room with artificial light on a 12:12 hour light-dark cycle Animals were fed twice a day with Primate

Chow and water was provided ad libitum.

Sample collection

Macaques were anesthetized with ketamine hydrochlo-ride (10 mg/kg) just prior to physical exams and sample collection Infant macaques were anesthetized for exams when they reached 3–4 months of age Samples of blood (1–8 ml) were collected from the dams and infants weekly for 8 weeks, then biweekly and monthly

Blood was collected in tubes with EDTA anticoagulant for enumeration of CD4+ T cells by flow cytometric evaluations as described previously [27] For analysis of virus and antibody titers, blood was collected in acid cit-rate dextrose anticoagulant and centrifuged at 1550 rpm for 15 minutes Plasma was removed and stored at -80°C PBMCs were purified from blood samples using Lym-phocyte Separation Medium from ICN (Aurora, OH) and washed with phosphate buffered saline prior to lysis and DNA purification DNA was isolated from PBMC of cryo-preserved tissues using Bio Rad Genomic DNA Isolation kit, and quantified by A260 measurement Flow cytometric determination of lymphocyte subsets was performed as described [27]

Approximately 1 ml of milk was collected by manual expression at the same time points as blood and immediately stored on ice Milk samples were separated into cellular and supernatant fractions by centrifugation

at 1550 rpm for 15 minutes The fat layer was suctioned off, and supernatant and cellular fractions were stored separately at -80°C

Reverse Transcription of SIV RNA

Viral cDNA was prepared from free virus particles con-tained in plasma or milk for viral RNA quantitation assays Virus was purified from the cell-free fraction of

milk or blood plasma by centrifugation at 22,000 × g for

1 hour Viral pellets from 1 ml of sample were solubilized

in 1 ml of Trizol Reagent (Life Technologies, Rockville, MD), and RNA was purified as per manufacturer proto-cols, with the final RNA sample resuspended in 30 µl of water Reverse transcription (RT) reactions contained 1 × PCR buffer II (50 mM KCl, 10 mM Tris-HCl, Ph 8.3), 5.0

mM MgCl2, 0.5 mM dNTPs, 2.5 uM random hexamers, 10

U Rnase inhibitor 25 U MultiScribe reverse transcriptase

and 3 µl of sample RNA (10% of total) Reaction condi-tions were 15 min at 42°C, 5 minutes at 95°C, and 5 minutes at 4°C

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Real Time RT-PCR Taq-Man assay

SIV RNA copy number in plasma and milk samples was

quantitated by real-time RT-PCR amplification based on a

previously described assay [42] that amplifies a region in

the SIV LTR using a 7700 ABI PRISM Sequence Detector

(Applied Biosystems, Foster City, CA) Virions expressed

in milk and plasma were purified and reverse-transcribed

to cDNA in a 10 µl total reaction volume as described

above Quantitation reactions were done with duplicate

cDNA samples, each prepared from 10% of total sample

RNA The cDNA was added to a PCR master mix

contain-ing 5.5 mM MgCl2, 1 × TaqMan buffer A, 0.5 mM dNTPs,

600 mM each of forward and reverse primers, 150 nM of

TaqMan probe, and 1.25 U AmpliTaq Gold, yielding a 25

µl total reaction volume Primer sequences were

-5'TTGAGCCCTGGGAGGTTCT3', and

5'GCCAAGTGCTGGTGAGAGTCT3' and Probe

-6FAM-AACACCCAGGCTCTACCTGCTAGTGCTG-TAMRA All

reagents were from Applied Biosystems Following a 10

minute incubation at 95°C, 40 cycles of amplification

were performed (94°C for 15 sec., and 60°C for 60 sec.)

in a 7700 ABI PRISM Sequence Detector SIV copy

num-bers in unknown samples were calculated from a standard

curve generated from serial dilutions of a RNA standard

amplified in each assay A plasmid containing SIV LTR

sequences (kindly provided by M Murphey-Corb,

Univer-sity of Pittsburgh) was transcribed in vitro to generate the

RNA standard Purified, standard RNA was quantified by

A260 measurements, and based on the calculated

extinc-tion coefficient for the transcript sequence/length was

serially diluted from 107 to O copies The dilution series

was amplified in the real time RT-PCR assay in triplicate

for generation of the standard curve This assay can

relia-bly detect 5 copies of SIV/ml and has a linear dynamic

range of 8 logs

SIV PCR Amplification

For detection of SIV infection in infant and adult

macaques, a 480 base pair fragment in the SIV envelope

was amplified in a nested PCR assay In these

amplifica-tion assays, 1 µg of DNA from PBMC, or cDNA (prepared

as described above) was added to a reaction mixture as

previously described [40] First round primers of

nucleo-tides 6709 to 6728 and 7406 to 7385 (numbering from

SIVmac239 sequence) were used Two microliters of the

first round reaction were added to a second round of PCR

with an internal set of primers of nucleotides 6845 to

6868 and 7327 to 7305(SIVmac239 reference)

SIV-specific antibody titers

SIV specific antibodies were determined by enzyme linked

immunosorbent assays (ELISA) as described by

Trypho-nas et al., [43] with the following modifications Plates

were coated with 3 µg/ml of a recombinant SIVmac239

gp130 (Quality Biologicals, Gaithersburg, MD) diluted in

PBS Blocking was done at 4°C overnight with 4% whey and 10% goat serum in PBS Plasma dilutions started at 1:5000 and were serially diluted four fold Milk was ini-tially diluted 1:50 then serially diluted four fold Peroxi-dase or biotin conjugated rhesus antisera (0.5 ug/ml) (Rockland Immunochemicals, Inc., Gilbertsville, PA) was added after washing and incubated for 1 hour at room temperature TMB developing solution (KPL, Gaithers-burg, MD) was added and incubated for 3 minutes fol-lowed by addition of 1 M H3PO4 to stop the reaction Absorbance values (at 450 nm) were determined by use of

a microplate reader

Statistical Analysis

Comparisons between viral loads, average viral loads and CD4+ CD3+ cell counts in different groups of macaques were performed by utilizing the non parametric two tailed Mann Whitney U Test A p-value of <0.05 was considered significant Viral loads that were detectable but not quan-tifiable were set at 50 copies/ml Undetectable viral loads were set at 1 copy

Authors' contributions

AMA conceived and designed the study, supervised all technical work, analysed and compiled data, and drafted the manuscript JR performed the antibody titers, ana-lysed data and helped draft the manuscript NL performed diagnostic PCR, designed and performed viral quantita-tion assays and participated in the design of the study LF coordinated blood and milk sample collection and processing, and participated in the design of the study MR participated in the design of the study and was responsible for clinical care of all animals and sample col-lection procedures All authors read and approved the final manuscript

Competing interests

None declared

Acknowledgements

We thank Richard Martin and Victoria Williams for technical work and Tara Randolph and William Gallaher for helpful discussions This work was sup-ported by NIH/NIDCR R01 DE12916 and NIH/NCRR P51 RR00164-39 The following reagent was obtained through the AIDS Research and Refer-ence Reagent Program, Division of AIDS, NIAID, NIH: SIVmac239 gp130 from Quality Biologicals, Gaithersburg, MD.

References

1. UNAIDS-WHO: AIDS epidemic update: 2003, http://

www.unaids.org/Unaids/EN/Resources/Publications/corpo- rate+publications/aids+epidemic+update+-+decem-ber+2003.asp 2003.

2. Newell ML: Mechanisms and timing of mother-to-child

trans-mission of HIV-1 Aids 1998, 12:831-837.

3 Leroy V, Newell ML, Dabis F, Peckham C, Van de Perre P, Bulterys M,

Kind C, Simonds RJ, Wiktor S, Msellati P: International

multicen-tre pooled analysis of late postnatal mother-to-child trans-mission of HIV-1 infection Ghent International Working

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